BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINRY DRN BG W/ANTI REFL

    MDR report key: 5643924 · Received May 10, 2016

    Report

    Report Number
    3011137372-2016-00094
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    April 7, 2016
    Report Date
    April 12, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FAQ
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLES HAVE BEEN RETURNED BUT THE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT OF INVESTIGATION: (ROOT CAUSE) THE RETURNED SAMPLE WAS TESTED AND PERFORMED AS DESIGNED. THERE IS NO FACTORY HISTORY OF ISSUES WITH THIS LOT OR MODEL NUMBER. IT IS ALWAYS POSSIBLE THAT THE PVC NRV WAS FOLDED IN THE PACKAGE AND DID NOT OPEN TO ALLOW THE URINE TO ENTER THE BAG. CORRECTIVE AND PREVENTATIVE ACTION TAKEN: NONE

    Description of Event or Problem · 1

    REPORTED EVENT: THE BAGS WOULD NOT ALLOW URINE TO FLOW IN THROUGH THE ANTI-REFLUX DEVICE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    REPORTED EVENT: THE BAGS WOULD NOT ALLOW URINE TO FLOW IN THROUGH THE ANTI-REFLUX DEVICE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300636 URINRY DRN BG W/ANTI REFL FAQ TELEFLEX MEDICAL 20141225

    Patients

    Seq Age Sex Outcome Treatment
    1